Under the Macedonian Law on Protection of Whistleblowers (2015) the protected reporting may be carried out as protected internal reporting, protected external reporting, or protected public reporting anonymously or confidentially, with good intent and based on reasonable assurance at the time of reporting that the information contained in the reports are true.
In the previous article, we reviewed in detail some of the proposals of the European Commission for a comprehensive overhaul of European pharmaceutical legislation, contained in the new draft Directive on the Union code relating to medicinal products for human use (the “Directive”) and in the draft Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency (the “Regulation”), which were not addressed by the Bulgarian media.
On 26 April 2023, the European Commission presented its long-awaited proposal for a comprehensive reform of the European pharmaceutical legislation. The reform aims to replace Directive 2001/83/EC on the Community code relating to medicinal products for human use with a new Directive (“the Directive”) and the integration into a new general regulation (“the Regulation”) of the Regulations establishing the European Medicines Agency and the centralised procedure for the authorisation of medicinal products (Regulation No 726/2004), orphan medicinal products (Regulation No 141/2000), advanced therapy medicinal products (Regulation No 1394/2007) and medicinal products for paediatric use (Regulation No 1901/2006).
We are pleased to share that the new, Sixteenth Edition of The Mergers & Acquisitions Review, by the Law Reviews, has been recently published. Nikolay Bebov, Damyan Leshev and Eleonora Mateina authored, for a second year in a row, the chapter on Bulgaria.
In January 2022, the new Regulation (EU) 2021/2282 of the European Parliament and the Council of the European Union of 15 December 2021 on health technology assessment (the “HTA Regulation”) entered into force on the territory of the European Union.
The circa $28 million transaction closed in early April, 2022. The closing followed clearance of the transaction from the Bulgarian National Bank and the Commission for Protection of Competition, as well the meeting of a range of other CPs.
In light of the obligation of the Bulgarian Commission for Protection of Competition (“BCPC”) to determine annually its enforcement priorities during the respective calendar year, taking into account the current economic situation, the need to increase competition in certain markets or to improve the market conditions, BCPC with its Decision No. 80/27.01.2022 adopted its annual priorities for initiating antitrust proceedings, and proceedings concerning unfair competition and unfair commercial practices.
January 28, 2022, Kluwer Competition Law Blog
The Mergers & Acquisitions Review provides a practical overview of global M&A activity and the legal and regulatory frameworks governing M&A transactions in major jurisdictions worldwide.
In 2019, Directive (EU) 2019/1937 on the protection of persons who report breaches of Union law (“the Directive”) was adopted at European Union (“EU” or “Union”) level. The objective of the Directive is to improve the application of EU law in certain areas by introducing a minimum level of harmonization with regard to mechanisms and protection measures when reporting breaches of Union law. Thus, the European legislator seeks to encourage those who have information about breaches of Union law to report it.
TBP proudly reports that Victoria Tzonkova and Damyan Leshev have been admitted as partners and Eleonora Mateina promoted to managing associate.
Kluwer Competition Law Blog